Transradial access devices, systems, and methods

ABSTRACT

Transradial access devices, systems, and methods. An exemplary device of the present disclosure for providing access to a vessel or other luminal organ and to prevent overperforation of the same comprises a needle having a needle tip and at least one current element positioned thereon or embedded therein at or near the needle tip, a sheath positioned around at least part of the needle, and a protractor in communication with the needle, whereby engagement of the protractor causes the needle tip to protract from the sheath through the aperture, and whereby release of the protractor causes the needle tip to retract through the aperture into the sheath. Activation of the at least one current element can facilitation vasodilation of the vessel or other luminal organ.

PRIORITY

The present application a) is related to, and claims the prioritybenefit of, U.S. Provisional Patent Application Ser. No. 62/105,576,filed Jan. 20, 2015, and b) is related to, claims the priority benefitof, and is a U.S. continuation-in-part application of, U.S.Nonprovisional patent application Ser. No. 13/283,024, filed Oct. 27,2011, which is related to, and claims the priority benefit of, U.S.Provisional Patent Application Ser. No. 61/407,211, filed Oct. 27, 2010.The contents of each of the aforementioned applications are herebyincorporated by reference in their entirety into the present disclosure.

BACKGROUND

Interventional procedures (including coronary angiography andangioplasty) are usually performed via transfemoral access. Althoughthis route provides relatively easy vascular access, it is associatedwith several shortcomings.

First, such a route is difficult to implement with patients that havesubstantial peripheral artery disease (such as aortoileofemoralobstructive disease), abdominal aortic aneurysm, groin infection, ormorbid obesity. Second, a small but potentially serious incidence ofvascular complications at the puncture site that may result insignificant groin hematoma, which could lead to necessary bloodtransfusions and/or require surgical repair.

A major advantage of the transfemoral route is puncturing the accessibleand large caliber femoral arteries is relatively easy. Although firstattempted two decades ago, the radial (transradial) approach is stillmore difficult to perform and has a higher failure attempt rate (1-9% inexperienced hands) primarily due to the smaller size of the vessels,whereby the needle tip may over-perforate during the procedure.Accordingly, the transradial technique has a steep learning curve.

Accordingly, alternative methods, and devices for performing transradialaccess would be well received by interventional practitioners treatingpatients meeting one or more of the aforementioned criteria. As such,there is clearly a need for a needle access device that allowsvisualization of puncture through blood retrieval and that allowsretraction of the needle tip to prevent overperforation.

BRIEF SUMMARY

In at least one embodiment of a device for providing access to a vesselor other luminal organ of the present disclosure, the device comprises aneedle having a needle tip, a sheath positioned around at least part ofthe needle, the sheath defining an aperture at a distal sheath end, anda protractor in communication with the needle, whereby engagement of theprotractor causes the needle tip to protract from the sheath, andwhereby release of the protractor causes the needle tip to retract intothe sheath. In another embodiment, wherein when the protractor is notengaged, the needle tip is positioned within the sheath. In yet anotherembodiment, at least part of the sheath is comprised of transparentmaterial. In an additional embodiment, at least part of the sheath iscomprised of translucent material.

In at least one embodiment of a device for providing access to a vesselor other luminal organ of the present disclosure, when the needle tippunctures a vessel or other luminal organ so that fluid within thevessel or other luminal organ is in communication with the needle tip,the fluid can also enter a lumen of the sheath and be detected withinthe sheath. In an additional embodiment, the protractor is selected fromthe group consisting of a button and a rotatable dial. In yet anadditional embodiment, the sheath further comprises a tapered distalend. In another embodiment, the tapered distal end of the sheath isconfigured to allow blood or other bodily fluids to pass between anoutside wall of the needle and the aperture so that the blood or otherbodily fluids can be detected within the sheath.

In at least one embodiment of a device for providing access to a vesselor other luminal organ of the present disclosure, the device furthercomprises a needle mechanism in communication with the needle and theprotractor, the needle mechanism operable to facilitate protraction andretraction of the needle tip from the sheath. In another embodiment, theneedle mechanism is selected from the group consisting of a spring, acompliant polymer, a coil, a sponge, and a bladder. In yet anotherembodiment, the device further comprises one or more wire aperturesdefined therethrough, the one or more wire apertures configured toreceive a wire. In an additional embodiment, the device furthercomprises a wire positioned through the one or more wire apertures, thewire configured to permit a second device to be delivered over the wire.In various embodiments, the wire comprises a guide wire.

In at least one embodiment of a method of accessing a mammalian bodilyvessel of the present disclosure, the method comprising the steps ofprotracting a needle tip from a sheath of a device, puncturing a bodilyvessel of a patient using the needle tip so that the needle tip accessesa lumen of the bodily vessel, and retracting the needle tip into thesheath of the device. In another embodiment, the step of retracting theneedle tip is performed upon detection of a fluid from the bodily vesselwithin the sheath of the device. In yet another embodiment, the bodilyvessel comprises a radial artery.

In at least one embodiment of a method of accessing a mammalian bodilyvessel of the present disclosure, the method further comprises the stepof advancing a wire through the device so that at least part of the wireis positioned within the lumen of the bodily vessel. In an additionalembodiment, the method further comprises the step of removing all orpart of the device from the patient, allowing at least part of the wireto remain within the lumen of the bodily vessel. In yet an additionalembodiment, the method further comprises the step of advancing a seconddevice over the wire so that at least part of the second device ispositioned within the lumen of the bodily vessel. In another embodiment,the step of advancing a second device comprises advancing a seconddevice selected from the group consisting of a catheter, catheters, aballoon catheters and a stent.

In at least one embodiment of a transradial heart catheterization methodaccording to the present disclosure comprises the steps of protracting aneedle tip from a sheath of a device, puncturing a radial artery of apatient using the needle tip so that the needle tip accesses a lumen ofthe radial artery, retracting the needle tip into the sheath of thedevice upon detection of blood from the radial artery within the sheathof the device, advancing a wire through the device so that at least partof the wire is positioned within the lumen of the radial artery,removing all or part of the device from the patient, allowing at leastpart of the wire to remain within the lumen of the bodily vessel, andadvancing a catheter over the wire so that at least part of the seconddevice is positioned within the lumen of the radial artery and at leasta portion of the patient's heart.

In at least one embodiment of a system for providing access to a vesselor other luminal organ of the present disclosure, the system comprises aneedle having a needle tip, a sheath positioned around at least part ofthe needle, the sheath defining an aperture at a distal sheath end, andan actuator in communication with the needle, whereby a first operationof the actuator causes the needle tip to protract from the sheath, andwhereby a second operation of the actuator causes the needle tip toretract into the sheath. In an additional embodiment, the system furthercomprises a needle mechanism in communication with the needle and theactuator, the needle mechanism operable to facilitate protraction andretraction of the needle tip from the sheath. In yet an additionalembodiment, the system further comprises a sensor coupled to the needleand operable to sense at least one bodily parameter. In anotherembodiment, the at least one bodily parameter comprises an impedance, anoxygen concentration, and a lactate concentration. In yet anotherembodiment, the system further comprises a wire coupled to the sensorand directly or indirectly coupled to the actuator, the wire capable oftransmitting a signal from the sensor to the actuator.

In at least one embodiment of a system for providing access to a vesselor other luminal organ of the present disclosure, the system furthercomprises a processor operably coupled to the sensor, the processoroperable to control actuation of the actuator. In another embodiment,and when the sensor senses a threshold bodily parameter, the processoroperates to control actuation of the actuator to protract or retract theneedle.

In at least one embodiment of a device, a wire, and/or a system of thepresent disclosure, said device, wire, and/or system comprises a) one ormore sensors (such as sensors 904), positioned upon and/or embeddedwithin the device, wire, and/or system; and/or b) an electrode (such asdetection electrode 1102), positioned upon and/or embedded within thedevice, wire, and/or system; and/or c) an electrode (such as detectionelectrode 1104), positioned upon and/or embedded within the device,wire, and/or system; and/or d) an electrode (such as excitationelectrode 1106), positioned upon and/or embedded within the device,wire, and/or system; and/or e) an electrode (such as excitationelectrode 1108), positioned upon and/or embedded within the device,wire, and/or system; and/or f) one or more current elements, positionedupon and/or embedded within the device, wire, and/or system. In anotherembodiment, the device, wire, and/or system is/are configured to obtainimpedance data of one or more of skin tissue, blood vessel tissue,and/or blood. In an additional embodiment, the device, wire, and/orsystem is/are configured to facilitate vasodilation of a vessel so tofacilitate radial access into the vasodilated vessel. In additionalembodiments, the device, wire, and/or system is/are configured to excitean electric field using one or more of said excitation electrodes, aneedle, and/or the wire. In yet additional embodiments, the device,wire, and/or system is/are configured to deliver a current sufficient tofacilitate/cause vasodilation using one or more of said excitationelectrodes, said one or more current elements 1200, a needle, and/or thewire.

In at least one embodiment of a device, a wire, and/or a system, whereinsaid device, wire, and/or system comprises a needle having a metallicneedle tip. In some embodiments, the metallic needle tip is configuredto and/or otherwise useful to obtain impedance measurements. In variousembodiments, the metallic needle tip is configured to and/or otherwiseuseful to deliver a current sufficient to facilitate/cause vasodilation.

In at least one embodiment of a device for providing access to a vesselor other luminal organ and to prevent overperforation of the same of thepresent disclosure, the device comprises a needle having a needle tipand at least one current element positioned thereon or embedded thereinat or near the needle tip; a sheath positioned around at least part ofthe needle, the sheath defining an aperture at a distal sheath end, aninterior space around the needle positioned therein, and having atapered distal end configured for percutaneous insertion into a vesselor other luminal organ, wherein at least a portion of a wall of thesheath is comprised of translucent or transparent material; and aprotractor in communication with the needle, whereby engagement of theprotractor causes the needle tip to protract from the sheath through theaperture, and whereby release of the protractor causes the needle tip toretract through the aperture into the sheath, wherein the device isconfigured so that when the needle tip punctures the vessel or otherluminal organ underneath skin after puncturing the skin and is advancedalong with the sheath so that the distal sheath end is also positionedwithin the vessel or other luminal organ and so that fluid within thevessel or other luminal organ is in contact with the needle tip,activation of the at least one current element can facilitationvasodilation of the vessel or other luminal organ and the fluid canenter the interior space of the sheath through the aperture and bevisually detected within the sheath through the portion of the sheathwall comprising the translucent or transparent material to indicate thatthe distal sheath end is positioned within the vessel or other luminalorgan so to prevent overperforation of the vessel or other luminalorgan. In at least one embodiment, the at least one current elementcomprises an excitation electrode configured to generate an electriccurrent. In at least one embodiment, the protractor is selected from thegroup consisting of a button and a rotatable dial. In at least oneembodiment, the tapered distal end of the sheath is configured to allowblood or other bodily fluids to pass between an outside wall of theneedle and the aperture when the needle is protracted from the sheath.

In at least one embodiment of a device for providing access to a vesselor other luminal organ and to prevent overperforation of the same of thepresent disclosure, the device further comprises a needle mechanism incommunication with the needle and the protractor, the needle mechanismoperable to facilitate protraction and retraction of the needle tip fromthe sheath. In at least one embodiment, the needle mechanism is selectedfrom the group consisting of a spring, a compliant polymer, a coil, asponge, and a bladder. In at least one embodiment, the device furthercomprises one or more wire apertures defined therethrough, the one ormore wire apertures configured to receive a wire. In at least oneembodiment, the device further comprises a wire positioned through theone or more wire apertures, the wire configured to permit a seconddevice to be delivered over the wire.

In at least one embodiment of a device for providing access to a vesselor other luminal organ and to prevent overperforation of the same of thepresent disclosure, the wire further comprises at least one wire currentelement positioned thereon or embedded therein at or near a wire tip,the at least one wire current element configured to generate an electriccurrent to cause vasodilation of the vessel or other luminal organ. Inat least one embodiment, the device comprises part of a system, whereinthe system further comprises a dilator configured to surround at leastpart of the sheath, the dilator further configured for partial insertioninto the vessel or other luminal organ; a guide wire configured forpartial insertion into one of a sheath lumen and a needle lumen, theguide wire further configured for advancement into the vessel or otherluminal organ; and an access catheter configured for advancement overthe guide wire and further advancement into the vessel or other luminalorgan. In at least one embodiment, the needle further comprises a sensorcoupled thereto or embedded therein, the sensor operable to sense atleast one bodily parameter.

In at least one embodiment of a system for providing access to a vesselor other luminal organ and to prevent overperforation of the same of thepresent disclosure, the system comprises a needle having a needle tipand at least one current element positioned thereon or embedded thereinat or near the needle tip; a sheath positioned around at least part ofthe needle, the sheath defining an aperture at a distal sheath end, aninterior space around the needle positioned therein, and having atapered distal end configured for percutaneous insertion into a vesselor other luminal organ, wherein at least a portion of a wall of thesheath is comprised of translucent or transparent material; and anactuator configured to facilitate movement of the needle within thesheath, whereby a first operation of the actuator causes the needle tipto protract from the sheath through the aperture, and whereby a secondoperation of the actuator causes the needle tip to retract through theaperture into the sheath, wherein the system is configured so that whenthe needle tip punctures the vessel or other luminal organ underneathskin after puncturing the skin and is advanced along with the sheath sothat the distal sheath end is also positioned within the vessel or otherluminal organ and so that fluid within the vessel or other luminal organis in contact with the needle tip, activation of the at least onecurrent element can facilitation vasodilation of the vessel or otherluminal organ and the fluid can enter the interior space of the sheaththrough the aperture and be visually detected within the sheath throughthe portion of the sheath wall comprising the translucent or transparentmaterial to indicate that the distal sheath end is positioned within thevessel or other luminal organ so to prevent overperforation of thevessel or other luminal organ. In at least one embodiment, the systemfurther comprises a needle mechanism in communication with the needleand the actuator, the needle mechanism operable to facilitateprotraction and retraction of the needle tip from the sheath. In atleast one embodiment, the system further comprises a sensor coupled tothe needle and operable to sense at least one bodily parameter selectedfrom the group consisting of impedance, an oxygen concentration, and alactate concentration. In at least one embodiment, the system furthercomprises a wire coupled to the sensor and directly or indirectlycoupled to the actuator, the wire capable of transmitting a signal fromthe sensor to the actuator. In at least one embodiment, the systemfurther comprises a processor operably coupled to the sensor, theprocessor operable to control actuation of the actuator.

In at least one embodiment of a system for providing access to a vesselor other luminal organ and to prevent overperforation of the same of thepresent disclosure, when the sensor senses a threshold bodily parameter,the processor operates to control actuation of the actuator to protractor retract the needle. In at least one embodiment, the tapered distalend of the sheath is configured to allow blood or other bodily fluids topass between an outside wall of the needle and the aperture when theneedle is protracted from the sheath.

In at least one embodiment of a method for accessing a mammalian bodilyvessel and to prevent overperforation of the same of the presentdisclosure, the method comprising the steps of protracting a needle tipof a needle from a sheath of a device, at least a portion of a wall ofthe sheath comprising translucent or transparent material and the sheathcomprising an interior space around the needle positioned therein;percutaneously puncturing mammalian skin using the needle tip;puncturing a mammalian bodily vessel under the mammalian skin using theneedle tip so that the needle tip and a tapered distal end of the sheathof the device surrounding the needle tip access a lumen of the mammalianbodily vessel and operating at least one current element positioned uponor coupled to at least one of the needle and a wire positioned at leastpartially within the wire to cause vasodilation of the mammalian bodilyvessel; and retracting the needle tip into the sheath of the device uponvisual detection of blood from the mammalian bodily vessel within theinterior space of the sheath of the device through the portion of thesheath wall comprising the translucent or transparent material so toprevent overperforation of the vessel or other luminal organ. In atleast one embodiment, the method further comprises the step of advancingthe wire through the device so that at least part of the wire ispositioned within the lumen of the mammalian bodily vessel.

The present disclosure includes disclosure of a device, a wire, and/or asystem, wherein said device, wire, and/or system comprises one or moresensors, positioned upon and/or embedded within the device, wire, and/orsystem; and/or one or more electrodes, positioned upon and/or embeddedwithin the device, wire, and/or system; and/or one or more currentelements, positioned upon and/or embedded within the device, wire,and/or system. In at least one embodiment, the device, wire, and/orsystem is configured to obtain impedance data of one or more of skintissue, blood vessel tissue, and/or blood. In at least one embodiment,the device, wire, and/or system is configured to facilitate vasodilationof a vessel so to facilitate radial access into the vasodilated vessel.In at least one embodiment, the device, wire, and/or system isconfigured to excite an electric field using one or more of one or moreelectrodes, a needle, and/or the wire. In at least one embodiment, thedevice, wire, and/or system is configured to deliver a currentsufficient to facilitate/cause vasodilation using one or more of saidelectrode electrodes, said one or more current elements, a needle,and/or the wire.

The present disclosure includes disclosure of a device, a wire, and/or asystem, wherein said device, wire, and/or system comprises a needlehaving a metallic needle tip. In at least one embodiment, the metallicneedle tip is configured to and/or otherwise useful to obtain impedancemeasurements. In at least one embodiment, the metallic needle tip isconfigured to and/or otherwise useful to deliver a current sufficient tofacilitate/cause vasodilation.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a side view of a device for providing access to a vessel orother luminal organ in a first configuration, according to at least oneembodiment of the present disclosure;

FIG. 2 shows a side view of a device for providing access to a vessel orother luminal organ in a second configuration, according to at least oneembodiment of the present disclosure;

FIG. 3 shows a side view of a device for providing access to a vessel orother luminal organ in a first configuration and at least partiallywithin a bodily vessel, according to at least one embodiment of thepresent disclosure;

FIG. 4 shows a side view of a device for providing access to a vessel orother luminal organ in a second configuration and at least partiallywithin a bodily vessel, according to at least one embodiment of thepresent disclosure;

FIG. 5A shows a wire positioned within a bodily vessel after entry usinga device for providing access to a vessel or other luminal organ,according to at least one embodiment of the present disclosure;

FIG. 5B shows a wire positioned within a bodily vessel with a seconddevice positioned thereon after entry using a device for providingaccess to a vessel or other luminal organ, according to at least oneembodiment of the present disclosure;

FIG. 6A shows a wire positioned within a sheath within a bodily vesselafter entry using a device for providing access to a vessel or otherluminal organ, according to at least one embodiment of the presentdisclosure;

FIG. 6B shows a wire positioned within a sheath within a bodily vesselwith a second device positioned thereon after entry using a device forproviding access to a vessel or other luminal organ, according to atleast one embodiment of the present disclosure;

FIG. 7 shows steps of an exemplary method of accessing a mammalianbodily vessel, according to at least one embodiment of the presentdisclosure;

FIG. 8 shows a side view of a portion of a device for providing accessto a vessel or other luminal organ having a dilator, according to atleast one embodiment of the present disclosure;

FIG. 9 shows a side view of a system for providing access to a vessel orother luminal organ, according to at least one embodiment of the presentdisclosure; and

FIG. 10 shows a block diagram of various components of a system forproviding access to a vessel or other luminal organ, according to atleast one embodiment of the present disclosure;

FIG. 11 shows a device and system having a needle wire with sensorsthereon, according to at least one embodiment of the present disclosure;

FIG. 12 shows a device and system having current elements, according toat least one embodiment of the present disclosure;

FIG. 13 shows a device and system having sensors and current elements,according to at least one embodiment of the present disclosure; and

FIG. 14 shows a device having a metallic needle tip useful to senseimpedance and/or introduce a current into the body.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings, and specific language will be used todescribe the same. It will nevertheless be understood that no limitationof the scope of this disclosure is thereby intended.

An exemplary embodiment of an access device (which may be used toprovide transradial access) according to the present disclosure is shownin FIGS. 1 and 2. As shown in FIGS. 1 and 2, device 100 comprises aneedle 102 having a needle tip 104. Needle 102, as shown in FIGS. 1 and2, may comprise the entire needle, or may comprise only a portion of alarger needle in at least another embodiment. Needle 102 is positionedat least partially within a sheath 106, whereby sheath 106 at leastpartially encircles needle 102 when at least part of needle 102 andneedle tip 104 protrude from sheath 106 (an exemplary firstconfiguration, as shown in FIG. 1), and whereby sheath 106 houses needle102 and needle tip 104 when needle 102 is retracted within sheath 106(an exemplary second configuration, as shown in FIG. 2). In at least oneembodiment, sheath 106 may comprise a stopcock 404 and/or a valve 406,as shown in FIG. 4, to regulate pressure within sheath 106, for example,and/or to release air and/or a fluid from within sheath 106.

Device 100, as shown in FIG. 1 and in various embodiments, comprises aprotractor 108 proximal to needle tip 104, wherein when protractor 108is engaged, at least part of needle 102 and needle tip 104 protrude fromsheath 106. Releasing protractor 108, as shown in FIG. 2, causes needle102 and needle tip 104 to retract within sheath 106.

As shown in FIGS. 1 and 2, protractor 108 is a mechanism capable ofbeing depressed and released, such as a physical button. However,additional embodiments of protractor 108 of the present disclosure maycomprise any number of other suitable mechanisms, such as a rotatabledial, capable of causing at least part of needle 102 and needle tip 104to protrude from and retract into sheath 106.

Sheath 106, in various embodiments of devices 100 of the presentdisclosure, is either completely or partially transparent ortranslucent, so that a user of device 100 can detect whether or notneedle tip 104 has engaged a vessel, such as a blood vessel, to anextent that blood from the blood vessel enters at least part of sheath106. In at least one embodiment, sheath 106 is comprised of transparentor translucent material, such as transparent or translucent plastic,rubber, or the like. When using device 100 to access a lumen of a bodilyvessel (such as a blood vessel), device 100 may be used to puncture theskin similar to a standard syringe/needle. When needle tip 104 puncturesa bodily vessel, a quantity of fluid from the vessel, such as blood inthe case of a blood vessel, can then enter the space inside sheath 106through aperture 200. Because at least part of sheath 106 is transparentor translucent in such an embodiment, a user can visually detect thepresence of blood within sheath 106, and can then retract at least partof needle 102 and needle tip 104 within sheath 106 to preventoverperforation.

In at least one embodiment of the present disclosure, such as theembodiment shown in FIGS. 1 and 2, sheath 106 comprises a tapered distalend 110, wherein when needle tip 104 protrudes from sheath 106, needletip 104 and the tapered distal end 110 of sheath 106 collectively form arelative point, so that when needle tip 104 engages/enters atissue/vessel, at least part of the tapered distal end 110 of sheath 110can then also engages/enters the tissue/vessel. Tapered distal end 110of sheath 106 is also configured to allow blood or other bodily fluidsto pass between an outside wall 112 of needle 102 and aperture 200 ofsheath 106, so that the blood or other bodily fluid is visible within alumen 114 of sheath 106.

Protrusion of needle tip 104 from sheath 106 and retraction of needletip 104 into sheath 106 by way of protractor 108 is facilitated by aneedle mechanism 116, such as those mechanisms capable of effectivelystoring and releasing energy, such as a spring, various compliantpolymers, coils, sponges, bladders, and the like, which can comprisevarious materials such as metals, plastics, polymers (nitinol, forexample), for example. Various needle mechanisms 116 of the presentdisclosure may involve thermo-electrical expansion, whereby an electriccurrent running therethrough may effectively cause needle tip 104 toprotract. Protraction, in various embodiments, may be on the order of0.1 mm-0.2 mm, but could be more or less depending on the application.

As shown in FIGS. 1 and 2, a spring (an exemplary needle mechanism 116)ultimately engages protractor 108 and needle 102, either directly orindirectly, to facilitate movement of needle 102 within sheath 106. Forexample, and as shown in FIG. 1, when protractor 108 is depressed,needle mechanism 116 causes needle tip 104 to protrude from sheath 106,and when protractor 108 is released, as shown in FIG. 2, needlemechanism 116 causes needle tip 104 to retract within sheath 106. Needlemechanism 116 may be compressed when protractor 108 is engaged as shownin FIG. 1 and may be expanded when protractor 108 is released as shownin FIG. 2 in at least one embodiment, and may be reversed, i.e. expandedwhen protractor 108 is engaged and compressed when protractor 108 isreleased, in various other embodiments, depending on the overallconfiguration of device 100. In at least one embodiment, thespring-loaded needle tip 104 is retractable, and can be advanced orretracted by a linear spring mechanism with a user's fingertip at theproximal end of device 100.

Various devices 100 of the present disclosure can be used, for example,to access the interior of a blood vessel as shown in FIGS. 3 and 4. Asshown in FIG. 3, protractor 108 can be depressed or otherwise engaged sothat needle tip 104 of device 100 protrudes from sheath 106. A vessel300 (such as a blood vessel, or other luminal organ within the body)would then be punctured by needle tip 104, and a user of the device 100would then look for blood or other fluid movement within sheath 106 toindicate access into vessel 300. Upon identification of blood or anotherfluid within sheath 106, as indicated in FIGS. 3 and 4 by way of fluidlevel 302, needle tip 104 would be retracted into sheath 106 to preventoverperforation of vessel 300, as shown in FIG. 4. A wire 400 (such as astandard 0.014″ guidewire), as shown in FIG. 4 may be advanced throughvarious wire apertures 402 of device 100 and through device 100 so thatat least part of wire 400 is positioned within vessel 300.

All or part of device 100 can then be withdrawn, whereby wire 400remains with access into vessel 300. In at least one example, and asshown in FIG. 5A, all components of device 100 are removed from vessel,with wire 400 remaining to facilitate entry of any number of wire-feddevices (exemplary second devices 600, such as various catheters,balloon catheters, and/or stents, for example) into vessel 300, as shownin FIG. 5B.

In at least another example, and as shown in FIG. 6A, at least onecomponent of device 100 may remain to provide access into vessel 300. Inat least one embodiment, and as shown in FIG. 6A, sheath 106 can bedisconnected from the remainder of device 100, so that when theremainder of device 100 is withdrawn from vessel 300, sheath 106, andoptionally wire 400 as shown in FIG. 6A, can remain to provide accessinto vessel 300. In at least one embodiment, and after device 100 isused to provide access into vessel 300, sheath 106 can be disconnectedfrom the remainder of device 100, the remainder of device 100 can beremoved, and then wire 400 can be inserted into sheath 106 so that atleast part of wire 400 enters the lumen of vessel 300. One or moresecond devices 600 can then either be inserted directly into vessel 300via sheath 106 or advanced over wire 400 positioned within sheath 106 asshown in FIG. 6B.

In various embodiments of devices 100 of the present disclosure, needle102 is relatively small (having an outer diameter of between about 0.3mm and 1.0 mm, for example, and an outer diameter of approximately 0.5mm in at least one embodiment), which is configured to pre-dilate intosheath 106 to allow access of needle tip 104, whereby needle 102 isretractable to provide a blunt non-perforation tip (formed by thetapered distal end 110 of sheath 106 and aperture 200) to preventoverperforation of a vessel 300. In at least one embodiment, needle 102has an inner diameter of about 0.35 mm. Retraction of needle 102 withinsheath 106 transforms device 100 from a puncture device to a sheath.Device 100, in any number of embodiments, can also be used to deliver asubstance (fluid, drug, etc.) into a patient's body, and/or used toremove a fluid/substance from the patient.

Steps of an exemplary method of using an exemplary device 100 of thepresent disclosure to provide access to a bodily vessel are shown inFIG. 7. As shown in FIG. 7, method 700 may comprise the steps ofprotracting needle tip 104 from sheath 106 (an exemplary protractionstep 702), and puncturing a bodily vessel of a patient (such as a radialartery, for example) using needle tip 104 so that needle tip 104accesses a bodily vessel lumen (an exemplary puncture step 704). Anexemplary method 700 further comprises the step of retracting needle tip104 within sheath 106 to prevent overperforation of the vessel 300 (anexemplary retraction step 706), which, in at least one embodiment, isfacilitated by the user identifying movement of a bodily fluid, such asblood, for example, within sheath 106 to indicate device 100 access intoa bodily vessel.

In at least one embodiment of a method 700 of the present disclosure,method 700 further comprises the step of advancing a wire 400 throughdevice 100 so that at least part of wire 400 is positioned within thebodily vessel (an exemplary wire advancement step 708). Method 700 mayfurther comprise the optional step of removing all or part of device 100from the patient so that wire 400 remains (an exemplary device removalstep 710). An exemplary method 700 may then further comprise the step ofadvancing a second device 600 over wire 400 so that at least part of thesecond device 600 is positioned within vessel 300 (an exemplaryadvancement step 712). Advancement step 712 may comprise, for example,advancement of a catheter (an exemplary second device 600) to apatient's heart during a heart catheterization procedure. Advancementstep 712 may also comprise, for example, advancement of any number ofother second devices 600 over wire 400 to access one or more otherorgans or areas within a patient's body. Various steps of method 700 maybe performed manually by a user and/or may be performed automatically asdescribed in further detail herein.

Access to a patient's blood vessel(s) by way of a transfemoral route ismost commonly performed, but the present disclosure provides methods oftransradial access and devices useful to perform the same. An exemplarydevice 100 of the present disclosure may be used to provide transradialaccess to a patient as described below.

Catheterization using a transradial approach involves accessing arelatively small artery in a patient's wrist and the subsequentadvancement of a catheter into the patient's heart. As such, transradialaccess, as referenced herein, involves the general access to a patient'svessel, such as a blood vessel, by way of the patient's wrist. Asreferenced above and in detail below, transradial access is moredifficult to perform than traditional transfemoral access, and variousembodiments of devices 100 of the present disclosure can be used with atransradial approach to provide effective access with significantlyreduced procedure risk.

Transradial access has several advantages over transfemoral access.First, a patient's upper extremities do not develop as muchatherosclerosis as the lower extremities, even with elderly patients,and hence access is always possible. Second, there are no nerves orveins of significant size near the usual site of puncture. Third, thehand's dual arterial supply from the radial and the ulnar artery adds anextra level of safety to the arterial puncture. Hence, if any thromboticor traumatic arterial occlusion may occur, this usually does notendanger the viability of the hand due to the presence of an adequatecollateral blood supply.

In addition, transradial access has significantly less vascularcomplications when compared to transfemoral access, and allows earliermobilization of patients post procedure as compared to transfemoralaccess. Transradial access can also be advantageous in patients withacute coronary syndrome where aggressive antithrombotic and antiplatelettherapy is often instituted, leading to a higher potential for accesssite bleeding complications with respect to femoral access. Furthermore,patient comfort is increased with early ambulation, and most patientswho have undergone cardiac catheterization from both the leg and wristwill strongly prefer the transradial route.

In various embodiments of devices 100 of the present disclosure, devices100 may further comprise a dilator 800. As shown in FIG. 8A, and in atleast one embodiment, a portion of device 100 may have a dilator 800surrounding at least sheath 106, so that insertion of a portion of adevice into a vessel 300, as described in detail herein, would alsoinvolve the insertion of a distal end 802 of dilator into vessel 300, sothat the overall insertion opening is larger than it would have been ifthe same sheath 106 was inserted into vessel 300 without dilator 800. Asshown in FIG. 8A, dilator 800 is larger than sheath 106, and theinherent size/thickness of dilator 800 would provide a larger accessopening into vessel 300 as described above. When using embodiments ofdevice 100 having a dilator 800 to access a vessel 300, dilator 800 maybe withdrawn along with the remainder of device 100, or all but sheath106, for example, so that sheath 106 and optionally a wire 400 insertedtherethrough remain to provide access into vessel 300.

Additional embodiments of devices 100 of the present disclosure maycomprise and/or include one or more features to facilitate automatedoperation of the same. For example, and in at least one embodiment of asystem 900 as shown in FIG. 9, system 900 may comprise one or moreportions of an exemplary device 100 and one or more automated features.

As shown in FIG. 9, an exemplary system 900 of the present disclosurecomprises a needle 102 having a needle tip 104, a sheath 106, and anactuator 902. Actuator 902, in various embodiments, can be coupleddirectly to needle 102, or indirectly coupled to needle 102 by way of aneedle mechanism 116 and optionally a protractor 108. Actuator 902, inat least one embodiment, is operable to protract and retract needle102/needle tip 104 from and into sheath 106, and may perform saidoperation without any direct manual engagement by the user. For example,when a user of system 900 would identify blood or another fluid withinsheath 106 after advancement of needle 102/needle tip 104 into a vessel300 either manually or using actuator 902, the user can operate actuator902 to retract needle 102/needle tip 104 into sheath 106. In at leastone embodiment of system 900 (or use thereof), protraction andretraction occurs automatically by way of actuator 902. In at least oneembodiment, actuator 902 can have a first operation to protract needletip 104, and a second operation to retract needle tip 104.

In various embodiments of systems 900 of the present disclosure, sheaths106 may not be transparent or translucent as otherwise described herein.For example, and in such an embodiment that would not readily allow auser to visualize blood or another bodily fluid within sheath 106,system 900 may further comprise one or more sensors 904, as shown inFIG. 9, operably coupled to needle 102/needle tip 104 to sense at leastone parameter and/or at least one parameter change. Such parameters orparameter changes may include sensing advancement of needle tip 104through skin, tissue, and a wall of vessel 300 so that needle tip 104comes into contact with blood within vessel 300. Such sensors 904 maycomprise one or more impedance sensors, whereby detected impedance ofblood versus tissue, for example, would trigger retraction of needle tip104 into sheath 106, and/or may comprise one or more oxygen sensors(sensing differences in oxygen concentration from tissues, arteries,and/or veins), lactate sensors (noting different concentrations oflactate in blood versus tissue), or any number of other sensors 904operable to detect an identifiable parameter within blood and/or anotherbodily fluid as being different than one or more surroundingtissues/vessels. Such sensors 904 could be electrical, electrochemical,chemo-mechanical, etc., in nature to facilitate the appropriate sensingto trigger advancement and/or retraction of needle 102/needle tip 104 ofsystem 900.

In at least one embodiment, needle 102/needle tip 104 may itself operateas a sensor given the metallic properties of various embodiments ofneedles 102. In other embodiments, and as shown in FIG. 10 (discussed infurther detail below), one or more sensors 904 are coupled to needle 102by way of a wire 906, whereby a first portion of wire 906 is coupled tosensor 904, and a second portion of wire 906 is coupled either directlyor indirectly to actuator 902. Wire 906, in various embodiments, isoperable to carry a signal from sensor 904 to actuator 902, eitherdirectly to actuator 902 or indirectly to actuator 902 by way of aprocessor 1000, referenced below.

A block diagram of various components of portions of an exemplary system900 of the present disclosure is shown in FIG. 10. As shown in FIG. 10,an exemplary system 900 may comprise an actuator 902, a sensor 904coupled to needle 102 and/or to processor 1000 by way of a wire 906,whereby processor 1000, actuator 902, and needle 102 are in operablecommunication with one another. In such an embodiment, for example,actuator 902 could be used to protract needle 102, and when sensor 904detects a parameter change indicative of vessel 300 access (such as thepresence of blood), a signal from sensor is either sent to or receivedby processor 1000 either through wire 906 or through actuator 902 toprocessor 1000, for example, so that processor 1000 operates actuator902 to retract needle 102. Generally speaking, and in at least oneembodiment, processor 1000 is operably coupled to sensor 902, whereinprocessor 1000 is operable to control actuation of actuator 902. In suchan embodiment, and when sensor 904 senses a threshold bodily parameter(such as, for example, the presence of blood or a parameter indicativeof blood), processor 1000 operates to control actuation of actuator 902to protract or retract needle 102/needle tip 104. The aforementionedembodiments are merely exemplary in nature, noting that various othercomponents described herein, or differing configurations of componentsshown in FIG. 10, may be made to facilitate the same or similar endresult.

The present disclosure includes disclosure of additional devices 100,wires 400, and/or systems 900 that utilize impedance to obtain locationdata in connection with various parts of the body during insertion of atleast part of the same therein. As noted above and as shown in FIG. 9,for example, exemplary systems 900 (or portions thereof) may compriseone or more sensors operably coupled to needle 102/needle tip 104 tosense at least one parameter and/or at least one parameter change. Suchparameters or parameter changes may include sensing advancement ofneedle tip 104 through skin, tissue, and a wall of vessel 300 so thatneedle tip 104 comes into contact with blood within vessel 300. Suchsensors 904 may comprise one or more impedance sensors 904, wherebydetected impedance of blood versus tissue, for example, would triggerretraction of needle tip 104 into sheath 106, and/or may comprise anynumber of additional sensors 904 operable to detect an identifiableparameter within blood and/or another bodily fluid as being differentthan one or more surrounding tissues/vessels. Such sensors 904 could beelectrical, electrochemical, chemo-mechanical, etc., in nature tofacilitate the appropriate sensing to trigger advancement and/orretraction of needle 102/needle tip 104 of system 900.

FIG. 11 shows an additional embodiment of a system 900 of the presentdisclosure, which in such an embodiment comprises at least an exemplarydevice 100 and a wire 400, with wire 400 having at least one sensor 904positioned thereon and/or embedded therein. As shown in FIG. 11, wire400 may comprise a plurality of sensors 904, such as two detectionelectrodes 1102, 1104 (exemplary sensors 904), positioned in between twoexcitation electrodes 1106, 1108. In such an embodiment, excitationelectrodes 1106, 1108 can be used to generate an electric field withinthe body to be detected using detection electrodes 1102, 1104, such asdisclosed within U.S. Pat. No. 7,454,244 of Kassab et al. Saidelectrodes 1102, 1104, 1106, and 1108, as shown in FIG. 11, and/orvarious other sensors 904 of the present disclosure, may be positionedat or near a distal end 1100 of wire 400, as shown in the figure. In atleast some embodiments, wires 400 in wire embodiments, and/or needles102 in needle embodiments as referenced herein, may use wire 400 and/orneedle 102 itself to excite some or all of the electric field. Saidplacement allows a user of system 900 to position distal end 1100 ofwire 400 relative to needle tip 104, so that puncture, positioningand/or advancement of needle tip 104 within lumen 350 of vessel 300, asshown in FIG. 11 for example, can be performed while wire 400 isobtaining impedance data (and/or other data, as referenced herein),using various sensor(s) 904 positioned thereon. In such an embodiment,for example, wire 400 and needle 102 having needle tip 104 may beadvanced and/or retracted simultaneously based upon data obtained bysensor(s) 904 positioned relative to (next to and/or near) needle tip104. For example, and during initial skin puncture, sensors 904configured to obtain impedance data may obtain impedance data oflevels/values corresponding to skin tissue, blood vessel 300 tissue,and/or blood, so that a user of system 900 or components thereof willknow where sensor(s) 904, and therefore needle tip 104, are locatedwithin the body. In at least another embodiment, a user may advance wire400 within the body first a given distance, and then subsequentlyadvance needle tip 104 a distance (which may or may not be the samedistance as the wire) based upon data provided by one or more sensors904 of wire 400. One or more of the aforementioned sensors 904, such aselectrodes 1102 and/or 1104, may also be positioned upon needle 102itself, as shown in FIG. 9.

Furthermore, various devices 100 and/or systems 900 of the presentdisclosure can be used in connection with radial access in conditions ofvasospasm and/or vasoconstriction. Vasospasm and/or vasoconstriction,which can be quite problematic when attempting radial access, iscurrently treated using one or more pharmacological agents which can notonly take substantial time to take effect, but are also not alwayseffective and may cause other problems and/or negative reactions withother agents taken by a patient, for example. In particular, the arms,in contrast with the lower body, are less susceptible to disease, notingthat peripheral leg diseases are more prevalent than, for example,peripheral arm diseases. As such, use of various devices 100 and/orsystems 900 of the present disclosure to facilitate vasodilation,especially in the arms, which are more vasoactive, would be quitebeneficial as noted below.

The disclosure of the present application includes devices 100 and/orsystems 900 having one or more current elements 1200 positioned thereonand/or embedded therein, said current elements 1200 configured to sendcurrent 1202 (as evidenced by the jagged lines in FIG. 12) into a vessel300 to facilitate vasodilation. One or more current elements 1200 may bepositioned upon and/or embedded within needle 102 (such as at or nearneedle tip 104), as shown in FIG. 12, and/or may be positioned upon orwithin wire 400, also as shown in FIG. 12, noting that current elements1200 on needle 102 and on needle 400 is not required, as a singlecurrent element 1200 would suffice. In at least one embodiment, currentelement 1200 and one of electrodes 1106 or 1108, for example, would bethe same element, and in such an embodiment, element 1200 (alsoconfigured as an electrode 1106 or 1108 or similar) would be configuredto generate an current sufficient to facilitate vasodilation (such as,for example, at or near 2 Hz over a 10-15 second interval) and wouldalso be sufficient to generate the electric field referenced above to besensed by detection electrodes 1102 and 1104. Use of such a currentelement 1200, as referenced herein, can introduce a current 1202sufficient for vasodilation since the electrical pulse hyperpolarizesthe membrane potential and prevents contraction of the vessel 300.

In at least one embodiment, needle 102 and/or wire 104 comprises asensor 904 and a current element 1200, such as shown in FIG. 13. Forclarity, an exemplary needle 102 and/or a wire 400 of the presentdisclosure may comprise a current element 1200 configured to introduce avasodilating current 1202, whereby such a current element 1200 may alsobe configured to generate an electric field detectable using a detectionelectrode 1102 and/or 1104, as referenced herein. In at least someembodiments, needles 102 and/or wires 400 may comprise one or morecurrent elements 1200 in addition to one or more sensors 904, such asfor example, where the one or more sensors 904 comprises electrodes 1102and 1104, and wherein needles 102 and/or wires 400 comprise one or moreadditional electrodes, such as electrodes 1106 and 1108. In at leastsome embodiments, one or both of a needle 102 and/or a wire 400 compriseone current element 1200 also configured as an excitation electrode andone or more additional sensors 904. In at least some embodiments of thepresent disclosure, current 1202 can be delivered from a current source1400 (such as shown in FIG. 14) to and/or through needle 102 and/or wire400, whereby needle 102 and/or wire 400 operate as current elements1200. Current source 1400 would be directly or indirectly a) coupled toneedle 102 in embodiments where needle 102 operates as a currentelement, b) coupled to wire 400 in embodiments where wire 400 operatesas a current element, and/or c) coupled to one or more current elements1200.

FIG. 14 shows an embodiment of a device 100/system 900 of the presentapplication previously discussed herein and shown in FIG. 14. As showntherein, device 100 comprises a needle 102 ending at a needle tip 104,and having features as shown in connection with other device 100embodiments of the present disclosure. However, and with such anembodiment, needle tip 104 itself operates, functions, and/or is used asa sensor 904 and/or other electrode as referenced herein. For example,and using needle tip 104 as an effective sensor, needle tip 104 canitself be configured to obtain impedance data and may obtain impedancedata of levels/values corresponding to skin tissue, blood vessel 300tissue, and/or blood, so that a user of device 100 or components thereofwill know where needle tip 104 is located within the body based uponsaid impedance data. Such an exemplary device embodiment shown in FIG.14 can also be used in connection with radial access in conditions ofvasospasm and/or vasoconstriction as referenced above, whereby needletip 104 itself operates, functions, and/or is used as a current element1200, such as shown in FIG. 12 and referenced herein. In such anembodiment, using needle tip 104 as an effective current element 1200,needle tip 104 would be configured and/or used to generate an currentsufficient to facilitate vasodilation (such as, for example, at or near2 Hz over a 10-15 second interval) and would also be sufficient togenerate the electric field referenced above to be sensed by detectionelectrodes 1102 and 1104 and/or another type of detector. Use of such aneedle tip 104 instead of a current element 1200, as referenced herein,can introduce a current 1202 sufficient for vasodilation since theelectrical pulse hyperpolarizes the membrane potential and preventscontraction of the vessel 300. Accordingly, and due to the metallicnature of a needle tip 104 configured as a sensor and/or to introduce acurrent, a metallic needle tip 104, in various device 100 and/or system900 embodiments of the present disclosure, can reduce or eliminate theneed for additional sensors and/or or current elements 1200 inconnection with said devices 100 and/or systems 900.

An advantage of the various embodiments of the present disclosure is theenablement of a retractable tip that prevents overperforation of a smallvessel. This, in conjunction with a transparent or translucent devicewall, provides the doctor with knowledge of the initial perforation asindicated by blood movement in the device. The advanced needle tip canthen be retracted to transform the needle into a non-blunt tip sheathwhich would not perforate the posterior vessel wall.

While various embodiments of devices, systems, and methods fortransradial access have been described in considerable detail herein,the embodiments are merely offered by way of non-limiting examples ofthe disclosure described herein. It will therefore be understood thatvarious changes and modifications may be made, and equivalents may besubstituted for elements thereof, without departing from the scope ofthe disclosure. Indeed, this disclosure is not intended to be exhaustiveor to limit the scope of the disclosure.

Further, in describing representative embodiments, the disclosure mayhave presented a method and/or process as a particular sequence ofsteps. However, to the extent that the method or process does not relyon the particular order of steps set forth herein, the method or processshould not be limited to the particular sequence of steps described.Other sequences of steps may be possible. Therefore, the particularorder of the steps disclosed herein should not be construed aslimitations of the present disclosure. In addition, disclosure directedto a method and/or process should not be limited to the performance oftheir steps in the order written. Such sequences may be varied and stillremain within the scope of the present disclosure.

1. A device for providing access to a vessel or other luminal organ andto prevent overperforation of the same, the device comprising: a needlehaving a needle tip and at least one current element positioned thereonor embedded therein at or near the needle tip; a sheath positionedaround at least part of the needle, the sheath defining an aperture at adistal sheath end, an interior space around the needle positionedtherein, and having a tapered distal end configured for percutaneousinsertion into a vessel or other luminal organ, wherein at least aportion of a wall of the sheath is comprised of translucent ortransparent material; and a protractor in communication with the needle,whereby engagement of the protractor causes the needle tip to protractfrom the sheath through the aperture, and whereby release of theprotractor causes the needle tip to retract through the aperture intothe sheath, wherein the device is configured so that when the needle tippunctures the vessel or other luminal organ underneath skin afterpuncturing the skin and is advanced along with the sheath so that thedistal sheath end is also positioned within the vessel or other luminalorgan and so that fluid within the vessel or other luminal organ is incontact with the needle tip, activation of the at least one currentelement can facilitation vasodilation of the vessel or other luminalorgan and the fluid can enter the interior space of the sheath throughthe aperture and be visually detected within the sheath through theportion of the sheath wall comprising the translucent or transparentmaterial to indicate that the distal sheath end is positioned within thevessel or other luminal organ so to prevent overperforation of thevessel or other luminal organ.
 2. The device of claim 1, wherein the atleast one current element comprises an excitation electrode configuredto generate an electric current.
 3. The device of claim 1, wherein theprotractor is selected from the group consisting of a button and arotatable dial.
 4. The device of claim 1, wherein the tapered distal endof the sheath is configured to allow blood or other bodily fluids topass between an outside wall of the needle and the aperture when theneedle is protracted from the sheath.
 5. The device of claim 1, furthercomprising: a needle mechanism in communication with the needle and theprotractor, the needle mechanism operable to facilitate protraction andretraction of the needle tip from the sheath.
 6. The device of claim 5,wherein the needle mechanism is selected from the group consisting of aspring, a compliant polymer, a coil, a sponge, and a bladder.
 7. Thedevice of claim 1, further comprising: one or more wire aperturesdefined therethrough, the one or more wire apertures configured toreceive a wire.
 8. The device of claim 7, further comprising: a wirepositioned through the one or more wire apertures, the wire configuredto permit a second device to be delivered over the wire.
 9. The deviceof claim 8, wherein the wire further comprises at least one wire currentelement positioned thereon or embedded therein at or near a wire tip,the at least one wire current element configured to generate an electriccurrent to cause vasodilation of the vessel or other luminal organ. 10.The device of claim 1, wherein the device comprises part of a system,the system further comprising: a dilator configured to surround at leastpart of the sheath, the dilator further configured for partial insertioninto the vessel or other luminal organ; a guide wire configured forpartial insertion into one of a sheath lumen and a needle lumen, theguide wire further configured for advancement into the vessel or otherluminal organ; and an access catheter configured for advancement overthe guide wire and further advancement into the vessel or other luminalorgan.
 11. The device of claim 1, wherein the needle further comprises asensor coupled thereto or embedded therein, the sensor operable to senseat least one bodily parameter.
 12. A system for providing access to avessel or other luminal organ and to prevent overperforation of thesame, the system comprising: a needle having a needle tip and at leastone current element positioned thereon or embedded therein at or nearthe needle tip; a sheath positioned around at least part of the needle,the sheath defining an aperture at a distal sheath end, an interiorspace around the needle positioned therein, and having a tapered distalend configured for percutaneous insertion into a vessel or other luminalorgan, wherein at least a portion of a wall of the sheath is comprisedof translucent or transparent material; and an actuator configured tofacilitate movement of the needle within the sheath, whereby a firstoperation of the actuator causes the needle tip to protract from thesheath through the aperture, and whereby a second operation of theactuator causes the needle tip to retract through the aperture into thesheath, wherein the system is configured so that when the needle tippunctures the vessel or other luminal organ underneath skin afterpuncturing the skin and is advanced along with the sheath so that thedistal sheath end is also positioned within the vessel or other luminalorgan and so that fluid within the vessel or other luminal organ is incontact with the needle tip, activation of the at least one currentelement can facilitation vasodilation of the vessel or other luminalorgan and the fluid can enter the interior space of the sheath throughthe aperture and be visually detected within the sheath through theportion of the sheath wall comprising the translucent or transparentmaterial to indicate that the distal sheath end is positioned within thevessel or other luminal organ so to prevent overperforation of thevessel or other luminal organ.
 13. The system of claim 12, furthercomprising: a needle mechanism in communication with the needle and theactuator, the needle mechanism operable to facilitate protraction andretraction of the needle tip from the sheath.
 14. The system of claim12, further comprising: a sensor coupled to the needle and operable tosense at least one bodily parameter selected from the group consistingof impedance, an oxygen concentration, and a lactate concentration. 15.The system of claim 14, further comprising: a wire coupled to the sensorand directly or indirectly coupled to the actuator, the wire capable oftransmitting a signal from the sensor to the actuator.
 16. The system ofclaim 14, further comprising: a processor operably coupled to thesensor, the processor operable to control actuation of the actuator. 17.The system of claim 16, wherein when the sensor senses a thresholdbodily parameter, the processor operates to control actuation of theactuator to protract or retract the needle.
 18. The system of claim 12,wherein the tapered distal end of the sheath is configured to allowblood or other bodily fluids to pass between an outside wall of theneedle and the aperture when the needle is protracted from the sheath.19. A method for accessing a mammalian bodily vessel and to preventoverperforation of the same, the method comprising the steps of:protracting a needle tip of a needle from a sheath of a device, at leasta portion of a wall of the sheath comprising translucent or transparentmaterial and the sheath comprising an interior space around the needlepositioned therein; percutaneously puncturing mammalian skin using theneedle tip; puncturing a mammalian bodily vessel under the mammalianskin using the needle tip so that the needle tip and a tapered distalend of the sheath of the device surrounding the needle tip access alumen of the mammalian bodily vessel and operating at least one currentelement positioned upon or coupled to at least one of the needle and awire positioned at least partially within the wire to cause vasodilationof the mammalian bodily vessel; and retracting the needle tip into thesheath of the device upon visual detection of blood from the mammalianbodily vessel within the interior space of the sheath of the devicethrough the portion of the sheath wall comprising the translucent ortransparent material so to prevent overperforation of the vessel orother luminal organ.
 20. The method of claim 19, further comprising thestep of: advancing the wire through the device so that at least part ofthe wire is positioned within the lumen of the mammalian bodily vessel.